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TeleMonitoring to Improve Substance Use Disorder Treatment After Detoxification

Primary Purpose

Enhanced Telephone Monitoring, Usual Care

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Telephone Monitoring
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Enhanced Telephone Monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Beginning an episode of inpatient detoxification at the Boston or Palo Alto Veterans Affairs medical facilities, and
  • have ongoing access to cell phone or land line telephone

Exclusion Criteria:

  • Significant cognitive impairment

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced Telephone Monitoring

Usual Care

Arm Description

Detox inpatients in the ETM condition will be expected to complete one 15-minute telephone call per week for 12 weeks.

Patients in the usual care condition will receive the care they would receive in the absence of a research project.

Outcomes

Primary Outcome Measures

Percent of Participants Who Had an Additional Inpatient Detoxification
Percent that had (yes) an additional inpatient detoxification 6 months following baseline assessment- additional inpatient detoxification was dichotomous, yes or no.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2014
Last Updated
February 7, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02269787
Brief Title
TeleMonitoring to Improve Substance Use Disorder Treatment After Detoxification
Official Title
TeleMonitoring to Improve Substance Use Disorder Treatment After Detoxification
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research program is intended to improve the treatment engagement and outcomes of Veterans who receive inpatient detoxification, and decrease their use of VA inpatient and emergency department services. It is intended to increase the use of substance use disorder care and 12-step mutual-help groups to benefit recovery, reduce rehospitalizations, and reduce costs for VA.
Detailed Description
Annually, about 25,000 Veterans receive inpatient detoxification (detox) for substance use disorders (SUDs). Detox is not SUD treatment; it is the medical management of withdrawal to prevent complications, which may be fatal. Detox inpatients who enter SUD treatment and peer-based mutual-help groups (e.g., Alcoholics Anonymous) have much better outcomes (less substance use, HIV/HCV risk behaviors, homelessness, rehospitalizations, Emergency Department visits) than those who do not. However, because of their unique characteristics (severe and chronic addictions, co-morbidities, lack of resources, self- and provider-perceptions as unsuitable for treatment), most Veterans discharged from inpatient detox do not enter SUD treatment. For many Veterans, a pattern of repeated inpatient detox, with each episode incurring a higher risk of overdose, occurs. Therefore, in its Uniform Services Handbook, Mental Health Operations places major emphasis on increasing the rate of SUD treatment initiation and engagement following detox to benefit Veterans' outcomes and prevent more use of costly health care. The primary objective of this project is to implement and evaluate Enhanced Telephone Monitoring (ETM) as a new and innovative telehealth intervention to facilitate the transition from inpatient detox to SUD specialty treatment (residential, outpatient, pharmacotherapy), thereby improving Veterans' outcomes and decreasing VA health care costs. In a randomized trial at two sites (VA Palo Alto and Boston), investigators hypothesize that patients receiving ETM, compared to patients in usual care (UC), will be more likely to enter and engage in SUD treatment and mutual-help, have better SUD and related outcomes, and have fewer and delayed acute care episodes. This project will also conduct a formative evaluation of how to implement ETM VA-wide, focusing on diverse subgroups of Veterans. Further, it will conduct a Budget Impact Analysis (BIA) to determine the impact of ETM on total costs of VA care. Investigators hypothesize that the higher costs associated with ETM (because patients will engage in SUD treatment) will be more than offset by its lower costs of acute care. Patients in the ETM condition will receive an in-person session while in detox, followed by coaching over the telephone for 3 months after discharge. The intervention will incorporate Motivational Interviewing, and Contracting, Prompting, and Reinforcing, to provide support while waiting for treatment, and facilitate entry into treatment and mutual-help, and improved responses to crises. Patients will be assessed at baseline and 3 and 6 months post-discharge for outcomes and non-VA health care; VA health care will be assessed with VA databases. GLMM analyses will be conducted to compare the UC and ETM groups on course of outcomes over time. The formative evaluation to inform the implementation of ETM will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Semi-structured interviews will be conducted with inpatient detox staff and patients to yield facilitators of ETM implementation and modifiable barriers with associated action plans. For the BIA, costs of ETM will be measured through microcosting methods. For patients in both the ETM and UC groups, all inpatient, residential, outpatient, and pharmacy care will be measured from VA utilization and cost files. In summary, Mental Health Operations is committed to eradicating the dangerous, costly pattern of Veterans obtaining inpatient detox services but not receiving the SUD treatment they need. Telehealth interventions, a promising way to improve treatment access and outcomes by SUD patients, have not been utilized with the challenging population of detox inpatients before. In accordance with others in this CREATE, this project will help to accomplish Mental Health Operations' goal of implementing the Uniform Handbook by increasing Veterans' access to, engagement in, and benefit from, SUD treatment services, particularly among Veterans who are using VA medical services and need SUD services but are not receiving them.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enhanced Telephone Monitoring, Usual Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Telephone Monitoring
Arm Type
Experimental
Arm Description
Detox inpatients in the ETM condition will be expected to complete one 15-minute telephone call per week for 12 weeks.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients in the usual care condition will receive the care they would receive in the absence of a research project.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Telephone Monitoring
Other Intervention Name(s)
ETM
Intervention Description
Detox inpatients in the ETM condition will be expected to complete one session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).
Primary Outcome Measure Information:
Title
Percent of Participants Who Had an Additional Inpatient Detoxification
Description
Percent that had (yes) an additional inpatient detoxification 6 months following baseline assessment- additional inpatient detoxification was dichotomous, yes or no.
Time Frame
6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Beginning an episode of inpatient detoxification at the Boston or Palo Alto Veterans Affairs medical facilities, and have ongoing access to cell phone or land line telephone Exclusion Criteria: Significant cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Timko, PhD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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TeleMonitoring to Improve Substance Use Disorder Treatment After Detoxification

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